GRAS (Generally Recognized as Safe)
RegulatoryAlso known as: Generally Recognized as Safe, GRAS status, Self-affirmed GRAS
A safety designation meaning an ingredient is generally recognized as safe for its intended use.
What It Means
GRAS is a designation under the Federal Food, Drug, and Cosmetic Act meaning a substance is generally recognized as safe for its intended use by qualified experts. GRAS status can be self-affirmed by the manufacturer or voluntarily notified to FDA. For supplements, GRAS status may exempt an ingredient from NDI notification requirements, though this is legally complex.
What It Is Not
GRAS is NOT FDA approval. Self-affirmed GRAS means the company's own experts determined safety — FDA may never have reviewed it. The 'generally recognized' standard requires published scientific evidence and expert consensus, but enforcement of this standard varies widely.
Evidence and References
- guidanceFDA GRAS notification program
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